Comparing Different Delivery Systems of Continuous Positive Airway Pressure in Neonates

Respiratory Distress Syndrome Clinical Trial

Official title:

Comparing Regional Ventilation in Neonates With Different Delivery Systems of Continuous Positive Airway Pressure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06038565
• Other study ID #: 2023P001796
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2023
• Est. completion date: October 18, 2024

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Jessica E Shui, MD
• Phone: 617-724-5994
• Email: jshui[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare late preterm newborn lung physiology when supported with different continuous positive airway pressure (CPAP) devices.

The main questions it aims to answer are:

• Which CPAP modality provides better breathing support in newborns with respiratory distress syndrome who are greater than 32 weeks gestational age?

• Does the lung physiology data predict the CPAP modality that will result in a shorter CPAP treatment duration?

Participants will wear a belt of electrodes on their chest (electrical impedance tomography) and have an esophageal balloon manometry measure lung physiology data for 2.5 hours while switching CPAP devices. Participants will then be randomly assigned to a CPAP device to support their breathing until they recover from respiratory distress syndrome.

Description:

Across centers, there is a variation in standard of care for the preferred device and interface to deliver continuous positive airway pressure (CPAP) to support neonatal functional residual capacity. CPAP, a type of noninvasive respiratory support, is commonly delivered to neonates by mechanical ventilators or underwater bubble devices (bubble CPAP). Variation also exists with the tubing used to deliver CPAP. One commonly used nasal interface is the RAM cannula (Neotech, Valencia, CA), made of a soft material with thin tubing walls and is designed to provide 60-80% occlusion of the nares. This contrasts with the occlusive interface intended to provide complete seal.

To provide evidence for standardization of CPAP delivery, clinical trials are needed to assess which modality of CPAP delivery is optimal for neonates with respiratory distress syndrome who are > 32 weeks and <37 weeks gestational age, an understudied population. The investigators propose to use electrical impedance tomography (EIT) paired with esophageal balloon manometry to assess neonatal lung physiology when supported with different modalities of CPAP. Furthermore, participants will be randomly assigned to A) physiology based CPAP vs B) one size fits all approach. The subjects will remain on the assigned modality of CPAP for the remainder of their respiratory distress syndrome treatment, and researchers will track which modality of CPAP results in a shorter CPAP treatment period and if this is expected based on the lung physiology data collected.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 18, 2024
• Est. primary completion date: October 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Hours to 36 Hours

Eligibility

Inclusion Criteria:

• medically stable neonates born >32 0/7 weeks and < 37 0/7 weeks gestational age, with birth weights > 1500 grams, are chronologically 12-36 hours old, and are receiving RAM cannula ventilator CPAP with positive end expiratory pressure (PEEP) between 5-6 cm water (H2O) and Fraction of inspired oxygen (FiO2) < 0.3 for the suspected diagnosis of respiratory distress syndrome

Exclusion Criteria:

• neonates with congenital anomalies that potentially will affect respiratory physiology, for example hypoplastic lungs or gastroschisis.

• neonates with contraindications for wearing an occlusive interface, for example epidermolysis bullosa which may have risk of worsening skin integrity at the pressure points of the occlusive interface, or a known small air leak that may potentially develop into a large pneumothorax.

• neonates with contraindications for placement of esophageal balloon manometry, for example hypoglycemia managed with extended feeding times greater than 30 minutes.

• neonates with contraindications for electrical impedance tomography, for example inability to ensure contact of the electrodes on the belt with the skin on the circumference of the chest due to presence of a chest tube dressing.

Related Conditions & MeSH terms

• Prematurity
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• RAM cannula ventilator CPAP
RAM cannula ventilator CPAP
• Occlusive interface bubble CPAP
Occlusive interface bubble CPAP

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (7)

Bhatia R, Davis PG, Tingay DG. Regional Volume Characteristics of the Preterm Infant Receiving First Intention Continuous Positive Airway Pressure. J Pediatr. 2017 Aug;187:80-88.e2. doi: 10.1016/j.jpeds.2017.04.046. Epub 2017 May 22. — View Citation

Courtney SE, Pyon KH, Saslow JG, Arnold GK, Pandit PB, Habib RH. Lung recruitment and breathing pattern during variable versus continuous flow nasal continuous positive airway pressure in premature infants: an evaluation of three devices. Pediatrics. 2001 Feb;107(2):304-8. doi: 10.1542/peds.107.2.304. — View Citation

Green EA, Dawson JA, Davis PG, De Paoli AG, Roberts CT. Assessment of resistance of nasal continuous positive airway pressure interfaces. Arch Dis Child Fetal Neonatal Ed. 2019 Sep;104(5):F535-F539. doi: 10.1136/archdischild-2018-315838. Epub 2018 Dec 19. — View Citation

Nascimento MS, do Prado C, Costa ELV, Alcala GC, Correa LC, Rossi FS, Amato MBP, Rebello CM. Effect of flow rate on the end-expiratory lung volume in infants with bronchiolitis using high-flow nasal cannula evaluated through electrical impedance tomography. Pediatr Pulmonol. 2022 Nov;57(11):2681-2687. doi: 10.1002/ppul.26082. Epub 2022 Aug 17. — View Citation

Prakash R, De Paoli AG, Davis PG, Oddie SJ, McGuire W. Bubble devices versus other pressure sources for nasal continuous positive airway pressure in preterm infants. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD015130. doi: 10.1002/14651858.CD015130. — View Citation

Prakash R, De Paoli AG, Oddie SJ, Davis PG, McGuire W. Masks versus prongs as interfaces for nasal continuous positive airway pressure in preterm infants. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD015129. doi: 10.1002/14651858.CD015129. — View Citation

Seddon PC, Davis GM. Validity of esophageal pressure measurements with positive end-expiratory pressure in preterm infants. Pediatr Pulmonol. 2003 Sep;36(3):216-22. doi: 10.1002/ppul.10284. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in electrical impedance	change in average electrical impedance with each CPAP delivery modality	2.5 hours during the lung physiology assessment
Primary	duration of CPAP treatment	compare groups Arm A-1, A-2 vs Arm B-1, B2; Compare groups Arm A-1, B-1 vs Arm A-2, B-2	through study completion, an average of 2 weeks after the lung physiology assessment
Secondary	lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in end expiratory lung impedance	change in end expiratory lung impedance (arbitrary units)	2.5 hours during the lung physiology assessment
Secondary	lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) vascular pulsatility	vascular pulsatility (arbitrary units)	2.5 hours during the lung physiology assessment
Secondary	lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) tidal volume	tidal volume (in milliliters) per weight (in kilograms)	2.5 hours during the lung physiology assessment
Secondary	lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in minute ventilation	change in minute ventilation (mL/minute)	2.5 hours during the lung physiology assessment
Secondary	lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in dynamic compliance	change in dynamic compliance (mL/cmH2O)	2.5 hours during the lung physiology assessment
Secondary	lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Respiratory rate	Respiratory rate (breaths per minute)	2.5 hours during the lung physiology assessment
Secondary	lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Oxygen saturation	Oxygen saturation (percentage)	2.5 hours during the lung physiology assessment
Secondary	lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Abdominal circumference	Abdominal circumference (cm)	2.5 hours during the lung physiology assessment
Secondary	lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) esophageal pressure change	esophageal pressure change (mm Hg)	2.5 hours during the lung physiology assessment
Secondary	lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) end expiratory pressure	end expiratory pressure via esophageal balloon manometry (mm Hg)	2.5 hours during the lung physiology assessment
Secondary	lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) pressure rate product	pressure rate product (cm H2O / min)	2.5 hours during the lung physiology assessment
Secondary	clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) Frequency of deviation	frequency of deviation from assigned CPAP treatment (percentage)	through study completion, an average of 2 weeks after the lung physiology assessment
Secondary	clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) frequency of exogenous surfactant administration	frequency of exogenous surfactant administration (percentage)	through study completion, an average of 2 weeks after the lung physiology assessment
Secondary	clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial)	respiratory support settings if deviated from assigned CPAP treatment (percentage)	through study completion, an average of 2 weeks after the lung physiology assessment